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In December 2021, the European Commission approved the extension of the current EU 2017/746 (IVDR) timelines, in accordance with IVDR article 110(3).
The new IVDR regulations came into effect on 26 May 2022 as scheduled. However, due to a serious shortage of notified body capacity, which made it impossible for most manufacturers to obtain IVDR certificates in time, the transition period has been extended. According to the transitional provisions published by the EU Commission, MRC Holland’s CE-mark obtained under the IVD Directive is still valid for almost all of MRC Holland’s products until 26 May 2026 or until an IVDR certificate will be obtained. The exception is SALSA MLPA Probemix P055 PAH: the CE-mark for this probemix is valid until 26 May 2025. In the meantime, we are in the process of obtaining an IVDR certificate for all of our IVD products placed on the market.
If you have any questions regarding the transitional provisions as specified in IVDR Article 110(3) or any other questions about our CE-IVD products, do not hesitate to email to our Regulatory Affairs team at RA@mrcholland.com and we will gladly answer them!